Recent studies question the clinical utility of tumor mutational burden as a biomarker for immuno-oncology response, and the FDA clearance includes no therapeutic indications.
The approval of its Omics Core assay for tumor-normal mutational profiling opens the door for payor reimbursement, which is key to reaching profitability, NantHealth said.
The company's software-related revenues grew year over year, but its sequencing and molecular analysis revenues declined.
NantHealth's net loss fell by 37 percent, to $14.7 million, as revenue from software-related revenue jumped by 23 percent while expenses fell.
The embattled company saw its net loss narrow during the first quarter, in part due to a new policy of giving away fewer nonreimbursed GPS Cancer and Liquid GPS molecular test orders than in the past.
The company's net loss more than doubled in Q4 to $49.1 million.
The hospital is in the process of clinically validating a sequencing pipeline for its pediatric cancer patients, with the goal of demonstrating clinical utility.
The issue, discovered in late October, affected TMB reporting for up to 800 FoundationOne CDx tests during a short period of time and was quickly resolved.
While orders of its Liquid GPS are increasing, Soon-Shiong expressed frustration with the slow pace of reimbursement and urged investor patience.
Quest also announced a partnership to provide supply chain expertise and run lab reference testing for Regional Medical Center Health System.